FDA Adverse Event
Injury
Summary report: N
ADAPTA SR
MDR report key: 2810868
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02424
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A DISCREPANCY BETWEEN CAPTURE MANAGEMENT AND THE IN-OFFICE MANUALLY MEASURED CAPTURE THRESHOLD. THE CAPTURE MANAGEMENT TEST WAS NOT RECOGNIZING EVOKED RESPONSE AS CAPTURE. CAPTURE MANAGEMENT WAS PROGRAMMED OFF. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA SR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | ADSR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |